The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

11076–11100 of 27089

  • ModerateFDA (Drugs)·D-0524-2024·2024-06-05

    Pain Wizard topical pain relief recalled for out-of-specification manufacturing

    ARG Laboratories recalls Pain Wizard pain relief cream nationwide due to manufacturing defect involving propylene glycol that did not meet specifications.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2024·2024-06-05

    Mako robotic surgery system software error causes treatment delays

    Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0523-2024·2024-06-05

    Aloe Gator SPF 40+ Sunscreen Recalled for Out-of-Specification Active Ingredients

    ARG Laboratories is recalling 4,013 units of Aloe Gator SPF 40+ sunscreen (Lot 04023C1) distributed nationwide because the active ingredient does not meet specifications.

    Product
    ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2024·2024-06-05

    Golden Tiger Pain Relieving Cream Recalled for Out-of-Specification Propylene Glycol

    ARG Laboratories is recalling Golden Tiger Natural Pain Relieving Cream nationwide due to use of a violative grade of propylene glycol during manufacturing that renders the active ingredient out of specification.

    Product
    NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Tube 4 oz (113.39 g), Mfr. for Golden Tiger USA Albuq, NM, UPC 1 82294 00002 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2024·2024-06-05

    FDA recalls Pain Wizard topical pain relief for ingredient specification issues

    ARG Laboratories recalled Pain Wizard topical pain relief roll-on due to active ingredient out of specification and violative-grade propylene glycol used in manufacturing.

    Product
    Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Roll-On 3 fl oz (88.7ml), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00010 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0508-2024·2024-05-29

    Phenylephrine Injection Recalled Due to Ephedrine Label Mix-Up

    Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.

    Product
    Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-1252-2024·2024-05-29

    Geissler's Supermarket Pink Lady Salmon Roll Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling Pink Lady Salmon & Avo Roll Combo sushi due to undeclared egg allergen. Consumers with egg allergies risk allergic reactions if they consume this product.

    Product
    Geissler's Supermarket Pink Lady Salmon &Avo Roll Combo (sushi roll) Ingredients read in part: "***INGREDIENTS: SALMON, AVOCADO, WATER. NORI.WHITESTEAMEORICE. VINEGAR. SUGAR. SALT.LEMON.MIRIN. WASABI. GINGER. SOYSAUCE (WHEAT, SOYBEANS,ALCOHOL) HOT SAUCE: SUGAR. MAYO. CHILI, SRIR
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1817-2024·2024-05-29

    Philips OmniLab Advanced + Ventilator May Experience Unexpected Therapy Loss

    Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.

    Product
    OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1811-2024·2024-05-29

    Optum Nimbus II Plus Infusion Pump Recall Due to Potential Failure Modes

    OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.

    Product
    Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1248-2024·2024-05-29

    Sammy's Milk Goat Formula Recalled for Misleading Infant Safety Claims

    Sammy's Milk Goat Milk Toddler Formula is recalled because the manufacturer made false claims it was safe for infants as a sole nutrition source. The product lacks FDA premarket approval and does not meet infant formula manufacturing standards.

    Product
    Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
    Category
    Food
    Distribution
    43 states
  • SevereFDA (Food)·F-1255-2024·2024-05-29

    Geissler's Supermarket Spicy Tuna Sushi Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling 193 units of Spicy Tuna sushi due to undeclared egg allergen. Products distributed in Connecticut and Massachusetts carry best-by dates of March 27 or 28, 2024.

    Product
    Geissler's Supermarket Spicy Tuna (8) Ingredients read in part: "***INGREDIENTS: RICE, NORI, AVOCADO, TUNA, MAYONNAISE, CHILI, SUGAR, SALT, GARLIC, ACETIC ACID, POTASSIUM SORBATE, SODIUM Bl SULATE, XANTHAN GUM, VINEGAR, ORANGE JUICE, ALCOHOL, HIGH FRUCTOSE CORN SYRUP, WATER, CIT
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1253-2024·2024-05-29

    Geissler's Supermarket Shrimp Tempura Recalled for Undeclared Wheat

    Geissler's Supermarket is recalling Shrimp Tempura and Spicy Shrimp sushi rolls due to wheat in the tempura batter that is not declared on the label. Consumers with wheat allergies risk allergic reaction.

    Product
    Geissler's Supermarket Shrimp Tempura and Spicy Shrimp Ingredients read in part: "***INGREDIENTS:RICE, NORI, AVOCADO, CUCUMBER,SHRIMP TEMPURA,SHRIMP, CAYENNE PEPPER PUREE, RED JALAPENO PEPPERS, ORGANIC DRIED GARLIC, CAYENNE POWDER, XANTHAN GUM, CITRIC ACID, SOY PROTEIN, VINEGAR
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1262-2024·2024-05-29

    Fresh soft white cheese recalled for potential Listeria contamination

    Tama Corporation is recalling Queso de mano (fresh soft white cheese) due to potential Listeria monocytogenes contamination. The affected product was distributed in Utah.

    Product
    Queso de mano, Fresh soft white cheese, NET WT 24 oz.(640g), Keep Refrigerated, plastic container, packed 12 plastic containers of 24 oz per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1254-2024·2024-05-29

    Geissler's Supermarket Spicy Salmon Sushi Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling Spicy Salmon sushi because the product contains egg in mayonnaise but does not declare this allergen on the label. This poses a serious risk to people with egg allergies.

    Product
    Geissler's Supermarket Spicy Salmon 9.6 oz Ingredients read in part: "***INGREDIENTS:RICE, NORI, AVOCADO, SALMON, MAYONNAISE, CHILI, SUGAR, SALT, GARLIC, ACETIC ACID, POTASSIUM SORBATE, SODIUM Bl SULFITE, XANTHAN GUM, VINEGAR, ORANGE JUICE, ALCOHOL, HIGH FRUCTOSE CORN SYRUP, WAT
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1812-2024·2024-05-29

    BiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm

    Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.

    Product
    BiPAP V30 Auto Ventilator, Part Number 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1814-2024·2024-05-29

    BiPAP A30 Ventilator Recall: Risk of Therapy Interruption and Respiratory Failure

    Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.

    Product
    BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1813-2024·2024-05-29

    BiPAP A40 ventilators risk therapy loss during alarm condition

    BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.

    Product
    BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1247-2024·2024-05-29

    Sammy's Milk Goat Formula Recalled for Misleading Infant Safety Claims

    Sammy's Milk goat formula is recalled for marketing it as safe for infants. The unapproved product does not comply with FDA infant formula manufacturing requirements.

    Product
    Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-1868-2024·2024-05-29

    Fresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor

    Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2024·2024-05-29

    Blood Pump Rotor Model F40015481 Rev A Recalled for Loose Guide Sheaves

    Fresenius Medical Care is recalling 45,880 Blood Pump Rotors (Model F40015481 Rev A) due to reports of loose or dislodged guide sheaves after use in clinical facilities.

    Product
    Blood Pump Rotor, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing

    Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Guide Sheave Failure Recall

    Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2024·2024-05-29

    Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance

    Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.

    Product
    Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0505-2024·2024-05-29

    Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

    Preferred Pharmaceuticals is recalling 66 bottles of Duloxetine 30mg capsules (Lot J2022G) due to manufacturing deviations that resulted in N-nitroso-duloxetine impurity above FDA limits.

    Product
    Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
    Category
    Drug
    Distribution
    5 states